Modernizing Medicine: Demonstrating a Policy of Prevention
SCOTT C. RATZAN
An undisputable fact of the 21st Century is that health
care spending continues to escalate. In the United States, 15 percent
of the country’s gross national product is spent on health care
and 75 of those costs are attributable to chronic disease. Chronic diseases
account for more than 70 of all deaths in the U.S., two-thirds of which
are caused by heart disease, cancer, stroke, chronic obstructive pulmonary
disease, and diabetes. Globally, 17 million people die each year from
cardiovascular disease. Furthermore, recent figures from the World Health
Organization predict that cardiovascular disease will be the most common
cause of death in developing countries by the year 2020.
Few people dispute the growing body of evidence that prevention
is effective through risk factor modifications such as smoking cessation,
exercise, and diet change. Scientific evidence and cost-effectiveness
measures suggest preventive services can postpone disease and disability,
permitting older adults to maintain functional independence and quality
of life.
Early detection and treatment of preventable chronic diseases
is an investment in America’s future as a healthy, productive nation.
With such a backdrop, legislators in the U.S. approved sweeping changes
to Medicare – the health care program for those over 65 –
including coverage of preventive medical tests and procedures, including
mammograms
and prostate and colon cancer screenings.
The same day that President Bush joined leaders in Washington,
DC signing hallmark Medicare legislation, an FDA Cardiovascular and
Renal Drugs Advisory Committee met in Gaithersburg, Maryland to discuss
whether aspirin should be recommended for primary prevention of myocardial
infarction. This was the third time the FDA has convened a committee
on this subject since 1989 to examine if there was adequate evidence
to substantiate the benefit and lack of harm for a daily dose of aspirin
to prevent a first heart attack.
In 1989, aspirin was recommended by the FDA advisory,
but overruled by the agency. In 2003, the FDA committee reviewed data
from published studies with over 55,000 patients in five large-scale
randomized trials. Four studies demonstrated a significant benefit in
reducing first heart attacks. Two were stopped early because the benefit
was overwhelming, which made it unethical to withhold treatment from
those in the control (placebo) group. The minor side effect was uncommon
stomach bleeding and very rare stroke.
Despite the demonstrated evidence and the endorsement
of low dose aspirin for individuals at risk for a first heart attack
from the U.S. Preventive Services Task Force, the American Heart Association,
the American College of Cardiology, the American Diabetes Association,
the FDA committee voted against recommending this prevention regimen
for Americans.
Without getting in to the intrinsic discussions that included
a savory need for evidence to present a definitive definition of a narrow
interpretation of efficacy, this decision demonstrates medicalization
over public health. Advancing primary prevention with low dose aspirin
would reduce the number of heart attacks in the U.S. by over 100,000
per year.
While the Committee request to have data from a number
of studies unequivocally demonstrating the relationship to avert death
for thousands who choose to take the 100 plus-year-old drug, this would
be a questionable multimillion dollar cost at the expense of heart disease
prevention. Yet, since this is such a low cost drug, costing pennies
a day
without any proprietary industry sponsor, spending such resources for
studies to offer further support would be misguided.
Many people criticize the policymaking process fraught
with multiple inputs – scientific evidence, consumer advocacy,
and political expediency, among others – the recent Medicare decision
will advance public health. The FDA advisory process hopefully is just
that – advisory. This may still present an opportunity for ethics,
reason and disease prevention to win out as policymakers choose to balance
multiple interests to advance health.
For the record, I will follow the professional organizations
and multidisciplinary U.S. preventive task force and take my low dose
aspirin each day. It is up to all of us who practice ‘‘health
communication’’ to discriminate amongst evidence and advance
disease prevention, health promotion, and ethical, efficacious treatment
by promoting prudent policymaking. While the ideal for evidence-based
medicine is an important goal, it is the health of the public that should
be the ultimate guide, rather than the intrinsic need for certainty
of scientific evidence.
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Scott C. Ratzan MD, MPA is Editor-in-Chief of the Journal of Health
Communication: International Perspectives.
